Neurofibromatosis type 2
Conditions
Interventions
Product Name: 89Zr-bevacizumab
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
INN or Proposed INN: Unknown
CAS Number: Unknown
Current Sponsor code: Unknown
Other descripti
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Patients aged 18 years or older - Confirmed diagnosis of NF2 by revised Manchester criteria (appendix C) - Provided written informed consent - Patients must have measurable disease, defined as at least one VS > 0.4 ml (on volumetric analysis) that can be accurately measured by contrast-enhanced T1-weighted cranial MRI scan. - Eligible and planned for bevacizumab treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Patients with a contra-indication for PET and MRI, such as pregnancy and metal elements. - Patients with a known allergy to substances used in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this feasibility study is to validate pre-treatment 89Zr-Bevacizumab PET/CT as an imaging biomarker for prediction of a hearing response to bevacizumab treatment in patients with NF2 related (vestibular) schwannomas. All patients will undergo standard-of-care treatment with an additional baseline 89Zr-Bevacizumab PET/CT. PET/CT imaging will be performed 4 days after intravenous infusion of 89Zr-Bevacizumab. The primary endpoint will be the correlation of the results of the pre-treatment 89Zr-Bevacizumab with the proportion of patients with confirmed hearing response (HR) and radiographic response (RR) to bevacizumab therapy.;Secondary Objective: Secondary end points are correlations of pre-treatment 89Zr-Bevacizumab PET/CT imaging with patient-reported outcome measures (PROM), cranial nerve (dys)function, kidney function and nontarget schwannoma response after bevacizumab treatment in NF2-patients.;Primary end point(s): All stated study parameters will be assessed for a correlation to the pre-treatment 89Zr-bevacizumab PET/CT, in order to determine its predictive ability for bevacizumab treatment effect. - Hearing Response (HR) ?- Word Recognition Score (WRS) ?- Pure Tone Average (PTA) / High Fletcher Index (HFI) - Radiographic Response (RR) ?- Size change in volumetric MRI (REiNS criteria [24]) ?- Changes in ADC values, microbleeds and perfusion;Timepoint(s) of evaluation of this end point: After 89Zr-bevacizumab PET/CT imaging en concomitant 6 month standard-of-care bevacizumab treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Durability of HR - Patient reported outcome measures (PROM) - Dizziness - Tinnitus - Quality of Life (QoL) - Facial nerve function: House Brackman scale (HB) - Facial spasms: yes / no, and need for Botox - Trigeminal nerve function - General neurological function - Peripheral schwannomas: size measurement and - when applicable - impairment level - Renal function;Timepoint(s) of evaluation of this end point: After 89Zr-bevacizumab PET/CT imaging en concomitant 6 month standard-of-care bevacizumab treatment | — |
Countries
Netherlands
Contacts
Public ContactA.J. Gelderblom
Leiden University Medical Center
Outcome results
None listed